# FDA recall D-0863-2020

> **Taro Pharmaceuticals U.S.A., Inc.** · Class I · drug recall initiated 2020-02-07.

## Product

Phenytoin Oral Suspension USP, 125 mg/5 mL potency,  8 fl oz (237 mL) Rx Only Mfd. by: Taro Pharmaceuticals Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A. Inc. Hawthorne, NY 10532,  NDC 51672-4069-1

## Reason for recall

Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may not resuspend as per the label copy instructions.

## Distribution

Distributed Nationwide in the USA.

## Key facts

- **Recall number:** D-0863-2020
- **Recalling firm:** Taro Pharmaceuticals U.S.A., Inc.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-02-07
- **Report date:** 2020-03-04
- **Termination date:** 2023-12-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hawthorne, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0863-2020

## Citation

> AI Analytics. FDA recall D-0863-2020. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-0863-2020. Source: US FDA. Licensed CC0.

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